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Neonatal Sepsis Clinical Cohort

Exploring the Pathological Characteristics and Pathogenesis of Neonatal Sepsis and Its Organ Dysfunction Based on Multi-Omics Technology

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112035
Enrollment
Unknown
Registered
2025-11-10
Start date
2025-11-12
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal sepsis

Interventions

Neonatal sepsis:None

Sponsors

Affiliated Hospital of Jining Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: The study population consists of neonates hospitalized in the NICUs of various centers who meet the suspected, clinical, or definitive diagnostic criteria for neonatal sepsis as outlined in the Expert Consensus on the Diagnosis and Treatment of Neonatal Sepsis (2024). 1. Suspected Diagnosis of Neonatal Sepsis For EOS: Clinical abnormalities within 72 h after birth. 2. Clinical Diagnosis of Neonatal Sepsis: Presence of clinical abnormalities, plus fulfillment of any one of the following criteria: At least two positive results from non-specific blood tests; Cerebrospinal fluid (CSF) findings consistent with purulent meningitis; Detection of pathogen DNA in blood or CSF. 3. Definitive Diagnosis of Neonatal Sepsis: Presence of clinical manifestations, plus a positive blood culture or culture of CSF (or other sterile body fluid).

Exclusion criteria

Exclusion criteria: 1. Neonates with inherited metabolic diseases or congenital malformations; 2. Neonates with severe asphyxia at birth, persistent pulmonary hypertension of the newborn, severe intracranial hemorrhage, or other such diseases; 3. Respiratory or circulatory failure caused by non-infectious factors; 4. Guardians who disagree with the neonate's participation in this study.

Design outcomes

Primary

MeasureTime frame
Septic shock;Neurodevelopmental disorders;diagnosed with sepsis;

Secondary

MeasureTime frame
In-hospital mortality;Pyogenic meningitis;Chronic lung disease;

Countries

China

Contacts

Public ContactWang Huabin

Affiliated Hospital of Jining Medical University

wanghb53@mail2.sysu.edu.cn+86 537 290 8139

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026